Page 13 - FACOT CHEMICALS - LINEA COMFORT

Biocide under transitional Legislation - Biocides

Biocides what are they?
According to Regulation (EU) 528/2012 Biocides products are:

> Any substance or mixture in the form in which it is supplied to the user, consisting of or containing or capable
of generating one or more active ingredients that destroy, eliminate and render harmless, prevent action
or have any other control effect on any harmful organism, by any means other than mere physical or me-
chanical action;
> Any substance or mixture, generated by substances or mixtures which do not fall as such in the above defi-
nition, used with the intent of destroying, eliminating, rendering harmless, preventing action
or have any other control effect on any harmful organism, by any means other than mere physical or me-
chanical action;
> A treated item that has a primary biocidal function shall be considered a biocidal product;

From PMC (Biocide under transitional Legislation) to Biocides
The difficult transition from PMC to Biocidal Products is essentially due to the need to develop European
legislation capable of adequately regulating all those products falling within the classification of Biocidal
products and that until now have been subjected to different regulations according to the country of in-
terest. Once fully implemented the revision program, the application of Regulation 528/2012, and subse-
quent modifications, will allow to have greater control of the active ingredients used for the preparation of
Biocidal products and at the same time to facilitate their marketing on the European market.
This updating of legislation is leading to a transitional period, in which national legislation overlaps Euro-
pean regulations.
Where active ingredients are not included in the list of approved substances, the placing on the market of
a product shall be governed by national laws. In the event that the active ingredients are included in the
approved list, the product must be authorized as a biocidal product. If even only one of the active ingre-
dients within a given preparation is not included in that list, the product may not be authorised as a biocidal
product.

Virucidal
The common meaning of this term is to destroy/kill viruses even if in reality viruses do not have their own me-
tabolism, so they cannot be considered living beings and, therefore, cannot be destroyed and/or killed but are
inactivated so that their viral load (amount of virus circulating) is reduced to non-disturbing levels. It is useful
to point out that among the various types of existing viruses there are those without envelope and those with
lipoprotein envelopes, including Covid-19. For this reason it is always recommended an accurate cleansing of
surfaces whatever they are, before disinfection with suitable products.

Levuricide/Yeast
The meaning of this term is to eliminate pathogenic yeasts such as Candida Albicans (saprotrophic fungus
which is a yeast belonging to the family of Saccharomycetes).

Cosmetic product
Article 2.1a) of Regulation (EC) No. 1223/2009 defines “cosmetic product“: “any substance or mixture inten-
ded to be applied to the outer surfaces of the human body (epidermis, hair root and hair, nails, lips, external
genitals) or on the teeth and mucous membranes of the mouth for the exclusive or main purpose of clea-
ning, perfuming, changing their appearance, protecting them, keeping them in good condition, correct body
odours”. Cosmetic products must be notified to the European Cosmetic Products Notification Portal (CPNP),
with identification of a responsible person and with the processing of Product Information File (PIF) documen-
tation. Cosmetic products cannot have properties or functions outside those listed above.
In general, hand washing products are cosmetic and their function is consistent with the definition and objecti-
ve of Regulation (EC) 1223/2009 to which these products must comply with.

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